The Biostatistics and Bioinformatics Facility (BBF) is a shared, institutional resource for biostatistics and bioinformatics collaboration and related methodological research. In July 2007, as a result of the FCCC internal Facility review process, the analysis and interpretation components of the Bioinformatics Facility were merged with the Biostatistics Facility to form the Biostatistics and Bioinformatics Facility. The Facility is recognized Center-wide as a critical component of the research infrastructure and serves investigators from all five Center Programs. It provides Center investigators with rigorous biostatistics and bioinformatics design, analysis and interpretation of experiments and studies. Facility staff are broadly skilled in quantitative and computational methods for clinical trials, pre-clinical studies, biological experiments, translational investigations and cancer prevention and control problems, BBF biostatisticians play a fundamental role in all phases of study design and execution and BBF bioinformaticians provide state-of-theart expertise for the analysis and exploration of diverse laboratory results including high throughput data. Their interactions with laboratory, cancer control, translational and clinical investigators have extended the interpretation of experimental data and contributed substantially to FCCC research activities. Six new Ph.D.-level BBF members were recruited during this funding cycle. Between January 2005 and June 2010, Facility members were coauthors of 145 manuscripts and logged 41,264 collaborative hours. BBF members produced 13 methodology/first author publications In clinical trial design, observational study methods and high throughput data analysis; and applied novel quantitative approaches and advanced methods to extend and support FCCC research. In one example. Facility members developed a novel clinical trial design that permits early stopping for rapid disease progression, an indication of therapeutic futility. This design was employed in a randomized Phase 11 trial in metastatic urothelial carcinoma that resulted in early termination of an ineffective therapy and identification of a promising new combination therapy. In 2009 the Facility logged 9,941 consulting hours with 78.8% in support of 72 peer-reviewed, funded investigators.